Rejecting an extraordinary request from industry to retract a controversial paper, Douglas Zipes, the editor-in-chief of HeartRhythm, has written a rare, highly pointed editorial defending the publication process. “If one disagrees with facts/statements in a publication,” writes the editor, Douglas Zipes, “there is a well-defined approach that can begin with a letter to the editor or submission of one’s own data for peer review to counter the conclusions in the article.”

“The peer review process is a time-honored, well-choreographed procedure that has served the intellectual world for several hundred years,” writes Zipes. “While occasional decisions may be incorrect, and fail to identify a submission of low (or high) quality, containing incorrect data, or even one that is fraudulent, in the main the system works.”

The publication of an editorial by Zipes was itself unusual, he noted: “I do not write many editorials because I feel my role as editor-in-chief is to be as impartial as possible.” In this case, “however, the recent events that transpired… have compelled me to speak out.”

Schloos offered the following comment in response to the Zipes editorial: “I applaud Dr. Zipes and HeartRhythm for publishing Dr. Hauser’s study. This important work should serve as a call to the cardiology community to increase their vigilance in detecting electrical failures in Riata/Riata ST ICD leads.”

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4 comments

I thought that I would point out the circumstances surrounding the Hauser article and the peer review process are somewhat unique. Generally in a publication like Heart Rhythm, experts in a highly specialized field can identify with the structure and technical aspects of the paper’s methods or results.

With the MAUDE database, there is no accepted scientific approach or universal understanding. In the past month, this has become very evident with the FDA proposing drastic revisions to device surveillance. Dr. Hauser’s methods and the organization of the MAUDE database were likely unfamiliar to the individuals on the peer review committee, and hence the entire premise for the peer review process is significantly undermined.

Excellent point, Eli. Clearly this should not be judged– or peer-reviewed– in the same way and with the same standards as a prospective, randomized trial. I don’t think anyone would make a claim that the Hauser paper is intended to be the final word on the subject. Instead, as I see it, the paper was a response to a clinical observation. In the complete absence of any better data, he found a possible safety signal. To say that this should not be published would be to say that in the absence of more reliable data no one should ever publish data raising safety concerns about medical devices. And since there is no reliable surveillance system, this would mean that no one could ever raise questions in print about medical devices!

With any luck, this episode, and others like it, will help propel current efforts to implement long-needed major improvements in the safety surveillance system.